PF-06863135 As Single Agent And In Combination With Immunomodulatory Agents In Relapse/Refractory Multiple Myeloma

  • Interventional
  • Not Recruiting
  • NCT03269136
Eligibility Details Visit Clinicaltrials.gov

A PHASE I, OPEN LABEL STUDY TO EVALUATE THE SAFETY, PHARMACOKINETIC, PHARMACODYNAMIC AND CLINICAL ACTIVITY OF PF-06863135, A B-CELL MATURATION ANTIGEN (BCMA) - CD3 BISPECIFIC ANTIBODY, AS A SINGLE AGENT AND IN COMBINATION WITH IMMUNOMODULATORY AGENTS IN PATIENTS WITH RELAPSED/REFRACTORY ADVANCED MULTIPLE MYELOMA (MM)

To assess the safety and tolerability at increasing dose levels of PF-06863135 in patients with relapse/ refractory multiple myeloma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

Study C1071001 is a Phase 1, open label, multi dose, multi center, dose escalation, safety, pharmacokinetic (PK) and pharmacodynamic study of PF-06863135 in adult patients with advanced multiple myeloma who have relapsed from or are refractory to standard therapy. This is a two part study; Part 1 will assess the safety and tolerability of increasing dose levels of PF-06863135 and Part 2 will evaluate safety and anti-myeloma activity of PF-06863135 at the RP2Ds determined in Part 1.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - Relapsed/refractory multiple myeloma

         - Progressed or are intolerant of established therapies including proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody

         - Performance Status of 0- 1 ( Performance Score 2 is permitted only if due to underlying myeloma)

         - Adequate bone marrow, hematological, kidney and liver function

         - Resolved acute effects of any prior therapy to baseline severity

         - Not pregnant

        Exclusion Criteria:

         - Recent history of other malignancies

         - History of active autoimmune disorders

         - Any form of primary immunodeficiency

         - Active and clinically significant bacterial, fungal, or viral infection

         - Evidence of active mucosal or internal bleeding

         - History of severe immune-mediated adverse event with prior immunomodulatory treatment

         - Major surgery within 4 weeks of study treatment start

         - Radiation therapy within 2 weeks of study treatment start

         - History of stem cell transplant (autologous or allogeneic) within 100 days prior to study enrollment

         - Donor Lymphocyte Infusion (DLI) within 30 days prior to study entry

         - Less than 30 days since last dose of antibody based therapies or less than 5 half-lives since last dose of previous therapy

         - Requirement for systemic immune suppressive medication except as permitted in the protocol

         - Current requirement for chronic blood product support

At a Glance

National Government IDNCT03269136

IRB#IRB17-1082

Lead SponsorPfizer

Lead PhysicianAndrzej Jakubowiak

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting